Individualized Virtual Reality in the Upper Extremity Rehabilitation of Hemiparetic Cerebral Palsy

Cerebral Palsy, Spastic Clinical Trial

Official title:

Individualized Virtual Reality in the Upper Extremity Rehabilitation of Hemiparetic Cerebral Palsy: an Evaluator Blinded, Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630678
• Other study ID #: 2017/08-23, KA-17050
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: November 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to investigate the effect of individualized virtual reality therapy on upper extremity functions of children with hemiparetic cerebral palsy.

Forty children (26 boys, 14 girls) with spastic hemiparetic cerebral palsy were included in this study. The primary outcome measure of this study was the Quality of Upper Extremity Skill Test, secondary outcome measures were the Modified Ashworth Scale and the "Reaching Map Test". The children were randomized into two groups. The first group was received conventional physiotherapy and virtual reality therapy for 60 minutes.The second group was received conventional physiotherapy and, activity training which the same movement patterns with virtual reality games for 60 minutes. Both treatments were given three times a week for eight weeks.

Description:

Participants Forty children (20 boys, 20 girls) were included in the study, and their demographic information was recorded. The participants were divided, using "randomizer.org" with a simple randomization method, into two different groups: the Virtual Reality or Activity Training (control) groups.

Study Design All children were assessed at baseline and after eight weeks of treatment. The children in both groups were evaluated by the same physiotherapist who was blinded. The treatment was given by a different physiotherapist who has been working in the field of pediatric physiotherapy for ten years Interventions The participants were randomized into two groups. The first group was received conventional physiotherapy and virtual reality therapy for 60 minutes. The second group was received conventional physiotherapy and, activity training which the same movement patterns with virtual reality games for 60 minutes. Both treatments were given three times a week for eight weeks.

The conventional physiotherapy interventions, including joint and muscle mobilization, strengthening, and stretching exercises by neurodevelopmental treatment principles and special for the needs of the child, was applied to both groups. The virtual reality therapy group received that simulate daily life and contain individual scenarios by using the USE-IT system for thirty minutes. USE-IT (Most Rehabilitation, Ankara, Turkey) is a 2D non-immersive virtual reality system that plays games on a 50-inches touchscreen. The children played "the matching, plumber, plumber, math, and car wash games" in accordance with their reaching map results. As the system detects not only hand but also object touch the real-life materials (cloths and hoses etc.) were used to stimulate grip and sense during games. The children in the activity training group received unilateral, bilateral, and bimanual activity training that supported manual skills for thirty minutes. Similar activity patterns were presented to the virtual reality group and activity training group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• diagnosed as spastic hemiparetic cerebral palsy by a physician,

• must be level I, II, and III according to the Gross Motor Function Classification System (GMFCS)

• must be level I, II, and III according to the Manuel Ability Classification System (MACS)

Exclusion Criteria:

• have cardiac or orthopedic contraindications for sitting, standing, and walking

• have orthopedic surgery to upper extremity and trunk in the last 6 months

• have used of spasticity-reducing medication or botulinum toxin injections to upper extremity or trunk in the last 6 months

• being severely mentally affected

• have any neurological conditions accompanying cerebral palsy (seizures, visual deficits, etc.)

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Paralysis

Intervention

Other:
• Virtual Reality Therapy
Virtual reality games were applied to participants for 30 minutes.
• Conventional Physiotherapy
Joint and muscle mobilization, strengthening, and stretching exercises by neurodevelopmental treatment principles were applied to participants for 30 minutes.
• Activity Training
Unilateral, bilateral, and bimanual activity training that supported manual skills for 30 minutes.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline "The Quality of Upper Extremity Skills Test Scores" at 8 weeks.	The Quality of Upper Extremity Skills Test was used to assess the function and quality of upper limb movements. This test has a total of 7 subdivisions, and the scoring of each section is calculated using a standardized formula. Each chapter is scored between 0-100 within itself. The first four section scores are used to calculate the total score. A high score indicates better the quality of the movement. The participant evaluated by a physiotherapist at baseline and after 8 weeks treatment.	At baseline and after 8 weeks treatment.
Secondary	Change from Baseline "The Modified Ashworth Scale Scores" at 8 weeks.	The Modified Ashworth Scale was used to assess the severity of spasticity of shoulder internal rotators, elbow, wrist, and finger flexors and elbow pronators, thumb abductors. The score is between 0-5 for each muscle. As the score increases, the severity of spasticity increases.	At baseline and after 8 weeks treatment.
Secondary	Change from Baseline "The Reaching Map Test Scores" at 8 weeks.	Forty balloons, randomized, appears on the screen, and the system asked the child to exploded the balloons. The child was positioned in front of the screen, and hip-knee angles were positioned 90° flexion. Through the special algorithm in the system, the "individual" access area was determined, and the scenario of the games was automatically adjusted accordingly. The areas that the child can reach on the screen were divided into five difficulty levels. Five levels from easy to very difficult describe as yellow, green, blue, navy blue and red areas were automatically calculated by the USE-IT system.	At baseline and after 8 weeks treatment.